Magnesium Sulfate 40 mg/mL
Magnesium Sulfate In Water For · INJECTION · Amneal Pharmaceuticals LLC
Magnesium Sulfate is a injection containing magnesium sulfate in water for at 40 mg/mL, taken intravenous. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Magnesium Sulfate
- Generic Name
- Magnesium Sulfate In Water For
- NDC Code (Product)
70121-1719- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 40 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216597
- Marketing Start
- 02/20/2023
Recall History
Med Prep Consulting, Inc.
Non-Sterility; mold contamination
Downing Labs, LLC
Lack of Assurance of Sterility
CMC Enterprise Pharmacy
Lack of sterility assurance.
The Compounding Pharmacy of America
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
FVS Holdings, Inc. dba. Green Valley Drugs
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Hospira, Inc.
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Hospira Inc.
Failed pH Specifications: 12 month stability testing
Amneal Pharmaceuticals, LLC
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
CMC Enterprise Pharmacy
Lack of sterility assurance.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Magnesium Sulfate in 5% Dextrose Injection is indicated for: • Prevention of eclampsia in patients with preeclampsia • Treatment of seizures and prevention of recurrent seizures in patients with eclampsia Magnesium Sulfate in 5% Dextrose Injection is indicated for ( 1 ): • Prevention of eclampsia in patients with preeclampsia ( 1 ) • Treatment of seizures and prevention of recurrent seizures in patients with eclampsia ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer via intravenous infusion pump ( 2.1 ) • Recommended loading dosage is 4 to 6 grams over 15 minutes followed by a recommended maintenance dosage of 1 to 2 grams every hour; maximum recommended dosage is 30 to 40 grams over 24 hours ( 2.2 ) • Obtain serum magnesium concentrations and assess clinical status to adjust the dose ( 2.2 ) • Administration beyond 5 to 7 days is not recommended ( 2.2 , 5.1 ) • In patients with severe renal impairment and/or urine output less than 0.5 mL/kg/hour, administer a 4 gram loading dose followed by a maintenance dosage of 1 gram every hour; do not exceed the maximum recommended dosage of 20 grams over 48 hours ( 2.3 ) • Do not administer Magnesium Sulfate in 5% Dextrose Injection with incompatible drugs through the same intravenous line, specifically with salicylates and alkali carbonates ( 2.4 ) 2.1 Important Administration Instructions Magnesium Sulfate in 5% Dextrose Injection is: • A clear solution. Visually inspect Magnesium Sulfate in 5% Dextrose Injection for particulate matter and discoloration prior to administration. Do not administer unless solution is clear and colorless to slightly yellow. • For i…
Contraindications
4 CONTRAINDICATIONS Magnesium Sulfate in 5% Dextrose Injection is contraindicated in patients: • with heart block or myocardial damage • in diabetic coma • with myasthenia gravis [see Warnings and Precautions (5.6) ] • Heart block or myocardial damage ( 4 ) • Diabetic coma ( 4 ) • Myasthenia gravis ( 4 , 5.6 )
Drug Interactions
7 DRUG INTERACTIONS Table 1 presents the potential clinical impact of medications that may be commonly administered concomitantly with Magnesium Sulfate in 5% Dextrose Injection in the clinical setting. Table 1: Potential Clinically Significant Drug Interactions with Magnesium Sulfate in 5% Dextrose Injection For drug incompatibility information [see Dosage and Administration (2.4) ] . Neuromuscular Blocking Agents Clinical Impact: • Potentiation and prolongation of neuromuscular blockade is possible with the concomitant use of magnesium sulfate and neuromuscular blocking agents [see Clinical Pharmacology (12.2) ] . • The underlying mechanism of this interaction may involve suppression of peripheral neuromuscular function by decreasing acetylcholine release, reduction of endplate sensitivity, and decreased muscle fiber excitability with magnesium sulfate therapy. Intervention: • Monitor respiration and the depth of neuromuscular blockade frequently (e.g., train-of-four monitoring) when a neuromuscular blocking agent is used concomitantly with Magnesium Sulfate in 5% Dextrose Injection. • Adjust the dosage of the neuromuscular blocking agent accordingly to maintain the desired level…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions have been identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: hypotension, circulatory collapse, cardiac depression including bradycardia Central Nervous System: central nervous system depression leading to respiratory paralysis, visual disturbances, flushing, sweating, hypothermia Metabolic: hypocalcemia with signs of tetany, hypermagnesemia Neurologic: lethargy, sedation, somnolence, myasthenic crisis Neuromuscular: depressed deep tendon reflexes, flaccid paralysis Pulmonary: decreased respiratory rate, pulmonary edema The most common adverse reactions are flushing, sweating, hypotension, depressed reflexes, flaccid paralysis, hypothermia, circulatory collapse, cardiac and central nervous system (CNS) depression proceeding to respiratory paralysis and hypocalcemia. Bradycardia, pulmonary edema, decreased respiratory rate, lethargy, sedation, somnolence, visual disturbances, and hypermagnesemia are also reporte…
Frequently Asked Questions
What is Magnesium Sulfate used for?
Magnesium Sulfate contains Magnesium Sulfate In Water For. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Magnesium Sulfate a controlled substance?
Magnesium Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Magnesium Sulfate?
The generic name for Magnesium Sulfate is Magnesium Sulfate In Water For. There are no other listed brand versions of Magnesium Sulfate In Water For.
What is the NDC code for Magnesium Sulfate 40 mg/mL?
The NDC (National Drug Code) for Magnesium Sulfate 40 mg/mL is 70121-1719, listed by Amneal Pharmaceuticals LLC.
Other Magnesium Sulfate Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)